S. 1214Senate118th Congress (2023-2025)In Committee

RARE Act

AI-Generated Summary

Updated January 20, 2026 at 6:23 AM UTC

The Retaining Access and Restoring Exclusivity (RARE) Act changes the orphan‑drug exclusivity rules in the Federal Food, Drug, and Cosmetic Act. It limits the seven‑year exclusive approval period to drugs that have the same approved use or indication, rather than just the same rare disease, and it adds a definition for “approved use or indication.” The changes apply to all drugs designated for rare diseases, affecting pharmaceutical companies and patients who rely on orphan‑drug protections.

Key Provisions

Amends Section 527 to replace “same disease or condition” with “same approved use or indication within such rare disease or condition.”
Updates language in subsection (b) to refer to “same approved use or indication for which such 7‑year period applies.”
Adds a definition of “approved use or indication” covering uses approved under the FD&C Act or licensed under the Public Health Service Act for orphan drugs.
Specifies that the amendments apply to any drug designated as an orphan drug, regardless of when it was designated or approved.

Legislative Activity

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4 earlier actions

SenateCalendars Latest Action

Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.

June 22, 2023

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SenateIntro Referral

Introduced in Senate

April 19, 2023

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

April 19, 2023

SenateCommittee

Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.

Health, Education, Labor, and Pensions Committee

May 11, 2023

SenateCommittee

Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report.

Health, Education, Labor, and Pensions Committee

June 22, 2023

SenateCalendars

Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.

June 22, 2023

Bill Text

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Reported to SenateIssued June 22, 2023

Calendar No. 109

118th CONGRESS

1st Session

S. 1214

IN THE SENATE OF THE UNITED STATES

April 19, 2023

Ms. Baldwin (for herself and Mr. Braun) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

June 22, 2023

Reported by Mr. Sanders, without amendment

A BILL

To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions.

Short title

This Act may be cited as the Retaining Access and Restoring Exclusivity Act or the RARE Act.

Limitations on exclusive approval or licensure of orphan drugs

(a)

In general

Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—

(1)

in subsection (a), in the matter following paragraph (2), by striking same disease or condition and inserting same approved use or indication within such rare disease or condition;

(2)

in subsection (b)—

(A)

in the matter preceding paragraph (1), by striking same rare disease or condition and inserting same approved use or indication for which such 7-year period applies to such already approved or licensed drug; and

(B)

in paragraph (1), by inserting , relating to the approved use or indication, after the needs;

(3)

in subsection (c)(1), by striking same rare disease or condition as the already approved drug and inserting same use or indication for which the already approved or licensed drug was approved or licensed; and

(4)

by adding at the end the following:

(f)

Approved use or indication defined

In this section, the term approved use or indication means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition.

(b)

Application of amendments

The amendments made by subsection (a) shall apply with respect to any drug designated under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless of the date on which the drug was so designated, and regardless of the date on which the drug was approved under section 505 of such Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262).

June 22, 2023

Reported without amendment